Questions?

Institutional Review Board

The Champlain College Institutional Review Board (IRB) will protect the safety, health, dignity and privacy of human subjects participating in research conducted by Champlain faculty, staff and students. The IRB will provide a structured review, aligning the College with the norms of acceptable practices and the requirements for research involving human subjects (as defined herein, see Definitions) established by the federal government (see 45 CFR 46 and 21 CFR 56) which conform to ethical standards for a particular research activity or method.

Anyone formally affiliated with Champlain College who engages in research involving human subjects, either on or off campus, must apply for IRB approval. Researchers not affiliated with Champlain College but who want to conduct research with human subjects under the auspices of Champlain College must apply for IRB approval. Anyone using unpublished institutional data from human subjects collected at Champlain College for research purposes, as defined herein, must have IRB approval.

The IRB now has a standard calendar, with one review meeting scheduled in each semester. The review dates are 27 October and 23 March of each academic calendar year.

Submissions to the IRB for review should be made with an appropriate amount of time to allow review BEFORE these dates. A protocol that is expected to require expedited review should be submitted at least three weeks before the next review date, while a protocol expected to require full review should be submitted at least eight weeks before the next review date.

Note that the final decision of the level of review rests with the IRB Chair who may be reached at irb@champlain.edu.

All research proposals involving human subjects must be submitted for IRB review. The IRB Chair will determine the level of review necessary for a project. Proposals will fall into one of three categories, as determined by the IRB Chair: Full Review, Expedited Review or Exempt.

Level 1 (Exempt):

Research involving human subjects that pose very little or no foreseeable risk to the health or welfare of the research subjects is generally exempt from an expedited or full-board review. Proposals will be deemed exempt by the Board Chair, with a report made to the full Board.

Level 2 (Expedited Review):

Research involving human subjects that pose minimal foreseeable risk to the health or welfare of the research subjects can be expedited by the IRB Chair. Projects eligible for expedited review will be voted on by three Board members chosen by the IRB Chair.

Level 3 (Full Review):

Research involving human subjects that pose more than minimal foreseeable risk is funded by federal grants, involves deception, or involves subjects from a group awarded special protections requires a full-board review.

F.A.Q.

General Questions

What is an IRB?

An IRB (Institutional Review Board) is a body that reviews research involving human subjects conducted under the auspices of an institution (like Champlain College), in order to oversee whether such work is being conducted according to the ethical standards of academic research. The rules governing IRB and human subjects research are controlled by the federal government, regulation 45 CFR 46.

Does my project qualify as “human subjects research”?

If your research involves interacting with human beings in any significant way, it could qualify as human subjects research. Research in this context is understood to be systematic investigation, including research development, testing, and evaluation designed to develop or contribute to generalizable knowledge. Research methods that entail significant interaction with humans include but are not limited to surveys, interviews, participant observation, focus groups, and experimentation. If you are unsure, you can always check with the Champlain College IRB Chair.

Do research projects conducted by Champlain students require IRB review?

For now, Champlain’s IRB policy regarding student work within a class is that it does not need IRB review. The instructor of the class acts as de facto principal investigator, and that person has the responsibility for ensuring her or his students’ research is conducted ethically. Any instructor who would like IRB input on student projects within their class is welcome to contact the Champlain College IRB Chair. Students conducting human subjects research outside of a class should submit their research for IRB review.

Do I need Champlain IRB review if I have IRB approval from another institution?

It is common practice for IRBs to grant each other a sort of “full faith and credit”, so if you have IRB approval from another recognized institution, Champlain will not require any additional IRB review.

How long will IRB review take?

IRB reviews are not an “on demand” service, and the amount of time a review takes can vary, depending on whether the submission requires expedited or full review. A calendar of dates and deadlines for the current academic year can be found on the Champlain College IRB main page.

Can I receive approval for a research project after the human subjects portion of the research project has begun? After it is finished?

No, and no. Research involving human subjects can only be given IRB approval if it has not yet begun. No retroactive approval is possible.

What if I have questions about the IRB process?

Questions about the Application Process

How do I start an IRB application?

What does the IRB look for in an application?

The IRB wants to see that a researcher has asked and answered the relevant questions of safety, equity, risk, consent, privacy, and benefit as they apply to the participants in their research. A full checklist of requirements can be found here.

Questions about Informed Consent

What does “informed consent” mean?

Informed consent is an acknowledgement that a research participant is fully aware of their participation in the research process, as well as the implications of doing so. Informed consent is defined more fully by the federal government, regulation 45 CFR 46.116.

What is the difference between “consent” and “assent”?

Assent is a verbal agreement to take part in research, generally required from children and others without the legal right to grant informed consent. Consent is written agreement to take part in research.

Do I always need informed consent/assent from my research participants?

Yes. Consent and/or assent (depending on the participant) should always be attained.

Do I always need a signed consent form to document my research participants’ consent?

Generally speaking, yes. There are certain circumstances wherein signed documentation of consent if not possible or advisable (e.g., to maintain the safety of a research participant), but such cases are the exception. An argument must be made by a researcher for not obtaining signed consent.

Questions about Human Subjects Research Training

What are the training requirements for IRB?

There are no special trainings for those seeking IRB approval at this time. Members of the IRB at Champlain College are required to complete a webinar offered by the Office for Human Research Protections or an equivalent training on ethical research practices. The tutorials for this webinar review human subjects regulations and policy, IRB requirements, and example scenarios. Champlain College’s IRB encourages those seeking to perform human subjects research to complete this training.